A Stent-Graft Prosthesis, System And Method For Improved Delivery Of A Stent-Graft Prosthesis

ABSTRACT

The present application discloses a stent-graft prosthesis and a method for navigating such stent-graft prosthesis e.g. to a branch vessel. A first stent-graft prosthesis may include a main body and at least one lateral side branch connected to the main body. A further stent-graft prosthesis according to examples has a body having a generally tubular wall structure, the wall structure of the further stent-graft prosthesis including an orifice element for receiving a guiding element. Preferably the wall structure has an overlap region for interconnection, e.g. to the first stent-graft prosthesis. The orifice element is then arranged at said overlap region, wherein said overlap region is preferably arranged at a proximal end region of said body. The guiding element preferably is a textile thread or suture thread, optionally with a radiopaque marker, such as a fiducial marker and/or a radiopaque elongate marker extending at least along a portion of a length of said guiding element.

BACKGROUND OF THE INVENTION Field of the Invention

This disclosure pertains in general to the field of tubular vascularprostheses. More particularly the disclosure relates to a vascularmedical device being a covered stent, stent graft, endoluminalprosthesis or endoprosthesis for liquid communication with one or moreside branch vessel(s), and a system of such devices, Also, medicalprocedures for deploying such devices and systems are disclosed. Thetarget site in a patient includes for instance at least a portion of anaorta of a patient. More particularly, treatment of at least a portionof an aorta of a patient by implantation of such a device or system in amedical procedure is disclosed. The medical procedure is preferablyminimally invasive vascular repair.

Description of the Prior Art

It is known to use modular covered stents or stent grafts for treatmentor repair of vascular disease, such as e.g. an aneurysm. WO 2005/027784discloses a system of modular covered stents for implantation in adiseased vessel, where the covered stents have apertures along themidsection of the covered stent. The apertures are used for aligningwith branch vessels of a main vessel so that further stents can beconnected at an aperture from a main vessel stent. The apertures need tobe precisely aligned with the ostia of the side vessels. From the mainvessel stent, a further stent graft protrudes then from each apertureinto the branch vessel.

An undesired issue with such known devices is that it is difficult forthe operator to correctly implant a stent-graft prosthesis in a mainvessel aligned with branch vessels. Apertures or branches from the mainvessel stent-graft prosthesis have to be correctly positioned in themain vessel in relation to the position of the branch vessels. Thebranch vessel is to be in liquid communication with the main vessel,i.e. through branch vessel stent-graft prostheses or portion of a largerstent graft unit with arms to the branch vessels.

In international patent application PCT/EP2017/062809 and EP 3 248 572A1 (published after the priority date of this present application) ofthe same applicant as the present application, which are incorporatedherein by reference in its entirety for all purposes, a stent-graftprosthesis and a method for navigating the stent-graft prosthesis to abranch vessel is disclosed. The stent-graft prosthesis includes a mainbody and at least one lateral side branch connected to the main body. Asystem of covered stents and a method for implanting, includinginterconnecting the stent-graft prostheses is also disclosed. Sidevessel stent-graft prosthesis are disclosed in PCT/EP2017/062809 and EP3 248 572 A1 which may be delivered to a side branch of a mainstent-graft prosthesis through a special guiding catheter having aguiding mate threadable over a guiding element. The system is unique andinnovative itself but may be further improved.

In EP 2 606 851 A1 a system is disclosed which includes an endoluminalprosthesis and a guide wire. However, navigation of side vessel stentgrafts is difficult.

In the prior art, systems of covered stent modules are provided withstent-graft prostheses that have a varying diameter in e.g. a taperedshape. They are connected by inserting a first folded tapered shapedstent-graft prosthesis into a second expanded tapered shaped stent-graftprosthesis. When the first stent-graft prosthesis is expanded, the twostent-graft prostheses form a connection. Such a system causes anunnecessary additional task for the operator to keep track of inaddition to keeping track of all the stent-graft prosthesis modules notonly being in the right order, in the right direction before and duringthe entire operation but also need to keep track of where and how thesetwo cones fit to each other. In contrary, examples of the presentdisclosure provide for a simpler, safer and quicker procedure ofimplantation.

There is a need for a further improved medical device and/or system, ormedical procedures that are safer, avoiding the aforementioned drawbacksof known systems and procedures. Preferably a device and/or system ormethod is desired that makes the operation times shorter and delivery ofthe devices easier and more reliable to a lateral branch vessel.Procedures are desired to be more easily performed by the operator.Simplified implantation procedure is desired. Complication rate isdesired to be reduced. Novel medical procedures with reduced patientrisk are desired. Simpler implantation is desired. Medical proceduresare desired, which can be performed despite the fact that they would beavoided today in a risk assessment of patients. For instance as knownstent systems would have implied too high risk for complications andopen chest surgery is no option for many patients, in particular elderlypatients), such simplified implantation, or devices facilitatingsimplified implantation, are desired. Less X-ray dosage needed duringthe procedure is also desired. Hence, there is a desire to be able toprovide novel medical procedures, implying reduced patient risk.

SUMMARY OF THE INVENTION

Accordingly, examples of the present disclosure preferably seek tomitigate, alleviate or eliminate one or more deficiencies, disadvantagesor issues in the art, such as the above-identified, singly or in anycombination by providing medical devices, systems, and methods accordingto the appended independent patent claims.

The present novel stent-graft prosthesis system allows, amongst others,for individual, single delivery of side vessel stent branches. Examplesof the invention described below allow advantageously reducing time forpart of or an entire procedure. Implantation time is shortened comparedto the prior art systems, and thus for instance the total dose isadvantageously reduced. The angle of the x-ray modality needs to bechanged less often than required by the prior art systems. Less amountof contrast medium is needed. Over all the below disclosure provides forreducing potential side effects for the patient. Moreover, the cost ofthe procedure will be reduced.

A reliable and stable delivery with precision positioning is providedwhile X-ray dosage is reduced as X-ray is not needed or substantiallyreduced to find the right overlap position for expansion of theprosthesis 600 at implantation.

The device and/or system may be used in medical procedures and methodsas described herein.

Aspects of the disclosure include, but are not limited to, a stent-graftprosthesis.

In a broad sense, a stent-graft prosthesis is disclosed. It comprises

a body having a generally tubular wall structure. The wall structure ofthe stent-graft prosthesis includes an orifice element for receiving aguiding element.

The stent-graft prosthesis may thus be delivered, preferably to a sidebranch of a main stent-graft prosthesis along a guiding element that ispreferably at a distal end permanently or releasably attached at theside branch, preferably at an end portion of the side branch having theguiding elements distal end attached thereto.

A kit is disclosed including a first (main) stent prosthesis having alateral branch and a second (side) stent-graft prosthesis according tosuch a broad sense. The first stent-graft prosthesis having at least onebendable and/or flexible guiding element being distally permanently orreleasably attached to an interior of the at least one the branches at adistance from a distal orifice of the branch.

A system is disclosed including such a kit, wherein the guiding elementis proximally extending through the orifice element for guiding thestent-graft prosthesis to the lateral branch towards the distal orificeof the branch during delivery, such that the orifice element is thestent-graft prosthesis upon delivery is arranged with a proximal overlapin the lateral branch.

A method of manufacture a stent-graft prosthesis is disclosed comprisingproviding a generally tubular wall structure of the prosthesis with anorifice element for receiving a guiding element.

A method of delivery a stent-graft prosthesis is disclosed, including ina vascular structure delivering a first stent-graft prosthesis having aside branch, the first stent-graft prosthesis having a guiding elementdistally permanently or releasably attached to an interior of the atleast one the branches at a distance from a distal orifice of thebranch, moving the second stent-graft prosthesis along the guidingelement arranged through an orifice element of the second stent-graftprosthesis, and expanding the second stent-graft prosthesis with aproximal overlap in the side branch when the orifice element stopsagainst a distal end of the guiding element.

The prosthesis 600 may include a body having a generally tubular wallstructure. The wall structure preferably includes an orifice element 610for receiving a guiding element 10. The orifice element is like aguiding mate in the prosthesis for receiving a guiding element 10 therethrough. The distal end of the guiding element 10 is arranged at aconnection point 11 at a first prosthesis. Advancing the prosthesis 600over the guiding element 10 arranged through the orifice element 610until it distally stops, provides a defined distal position of theprosthesis 10 during delivery and implantation in relation to the firstprosthesis.

The wall structure may have an overlap region for interconnection toanother stent-graft prosthesis. The orifice element is then preferablyarranged at the overlap region. The overlap region is preferablyarranged at a proximal end region of the prosthesis body.

The guiding element 10 is elongate and suitable to extend through bloodvessels and to be distally attached or connected to the body.

Preferably the guiding element 10 it is a textile thread or suturethread, optionally with a radiopaque marker, such as a fiducial markerand/or a radiopaque elongate marker extending at least along a portionof a length of the guiding element 10.

The guiding element 10 may alternatively be a (stiffer) elongate elementlike a wire. A wire has the advantage that it avoids buildup of a knotor muddle of the guiding element when a prosthesis (and/or catheter) isthreaded along it.

The orifice element may be an aperture in the tubular wall structure.The aperture is preferably an eyelet in a wall material of the wall andpreferably has a reinforced periphery edge or a reinforced peripheralregion such as in the wall material adjacent the eyelet. Thereinforcement may be provided by a suitable wire geometry of the stentstructure of the prosthesis. For instance a heat set wire or laser cutstructure may have an eyelet around the aperture/hole of the orificeelement 610 in the wall structure of the prosthesis.

The orifice element may be a side opening or aperture in the wallstructure.

The tubular wall structure has an outside. The orifice element may inexamples be arranged at the outside of the wall. The orifice element maybe an eyelet or a tubular element for receiving the guiding element 10.

The tubular wall structure has an inside. The orifice element may inexamples be arranged at the inside of the wall. For instance the orificeelement may include an elongate such as tubular structure for receivingthe guiding element 10. The elongate structure may be arranged at theinside of the wall proximally and oriented towards an aperture in thewall. The guiding element 10 may then be arranged through the apertureand the tubular structure.

Alternatively or in addition to tubular structure(s) outside and/orinside the tubular wall structure, multiple eyelet structures may beprovided at a suitable distance and along a suitable length to receivethe guiding element through the eyelet structures along the length. Theeyelet structures may be circular, oval or have other suitable crosssections.

The orifice element may be arranged at a rotational position of thetubular wall structure for facilitating a rotational position of thebody upon delivery.

The orifice element is in examples a guiding mate. The guiding mate isconfigured for receiving the guiding element, such that the stent-graftprosthesis is configured to slide along the guiding element 10 duringdelivery over the guiding mate 9 to the orifice of the first stent-graftto be connected to the second stent-graft, such as of the branch.

Delivery and deployment of the stent-graft prosthesis is done through adelivery lumen of a catheter. The guiding mate for receiving the guidingelement preferably has a distal end positioned proximally at a distancefrom the distal orifice at a connection point, such as of the sidebranch. In this manner the stent-graft prosthesis preferably extendsdistally beyond the connection point when the guiding mate 9 engages theconnection point.

The guiding element 10 is preferably made of a biodegradable material.

Aspects of the disclosure include, a kit of a first stent prosthesishaving a lateral branch and a second stent-graft prosthesis according tothe above aspect.

The first stent-graft prosthesis may have at least one bendable and/orflexible guiding element 10 being distally permanently or releasablyattached to an interior of the first stent-graft prosthesis at adistance from an orifice thereof. The guiding element 10 may be distallypermanently or releasably attached to at least at one of the branchesand at a distance from a distal orifice of the branch.

Aspects of the disclosure include, a system including the kit of theafore aspect. The guiding element is preferably proximally extendingthrough the orifice element for guiding the stent-graft prosthesis to alateral branch 3 towards the distal orifice of the branch 3 duringdelivery. In this manner, the stent-graft prosthesis is upon deliveryarranged with a proximal overlap in the lateral branch.

Aspects of the disclosure include, a method of manufacture a stent-graftprosthesis. The method may include providing a generally tubular wallstructure of the prosthesis with an orifice element for receiving aguiding element 10.

Aspects of the disclosure include, a method of delivery a stent-graftprosthesis. The method may include delivering a first stent-graftprosthesis having a side branch 3 in a vascular structure. The firststent-graft prosthesis having a guiding element distally permanently orreleasably attached to an interior of the at least one the branches (3)at a distance from a distal orifice of the branch 3. During delivery,the second stent-graft prosthesis is moved along the guiding elementarranged through an orifice element of the second stent-graftprosthesis. The second stent-graft prosthesis is thus expanded with aproximal overlap in the side branch 3 when the orifice element stopsagainst a distal end of the guiding element 10.

The guiding element 10 may provide securing of two prosthesis together.Upon expansion of the prosthesis 600 in the first prosthesis, a lockingelement may be threaded onto the distal end of the guiding element 10.The locking element may be a ratchet type locking element. The lockingelement may be a knot. The knot may be advanced along the guidingelement 10 by means of a known knot-pusher device. The portion of theguiding element 10 proximal of the positioned and locked locking elementmay be cut/removed out of the body.

The stent-graft prostheses discussed herein are in an exampleself-expanding, or in another example expandable by another device, suchas an inflatable balloon.

Further examples of the disclosure are defined in the dependent claims,wherein features for the second and subsequent aspects of the disclosureare as for the first aspect mutatis mutandis.

Some examples of the disclosure provide for an improved navigation ofand assembling of a stent-graft prosthesis or a plurality of stent-graftprostheses. The stents to be assembled are to provide fluidcommunication upon delivery and assembly. For instance, a stent-graftprosthesis may be advantageously positioned in a side branch vessel froma main vessel. Fluid communication may be provided from a firststent-graft prosthesis in the main vessel to a second stent-graftprosthesis in such side vessel. Fluid communication may also be providedin other configurations requiring overlapping assembly of a plurality ofmodular stent-graft prostheses.

The term covered stent or stent-graft prosthesis means a stent orstent-graft having an inner and/or outer liner, shell or being otherwisesurrounded by or provided with a liquid impermeable fabric or material.The covered stent can be partly or fully covered. A covered stent canalso be called a stent graft or an endoprosthesis. Generally thesestent-graft prostheses are tubular prostheses. The tubular prosthesissuch as stents, grafts, and stent-grafts (e.g., stents having an innerand/or outer covering comprising graft material and which may bereferred to as covered stents or stent-graft prosthesis) have beenwidely used in treating abnormalities in passageways in the human body.In vascular applications, these devices often are used to replace orbypass occluded, diseased or damaged blood vessels such as stenotic oraneurysmal vessels. For example, it is well known to use stent-grafts,which comprise biocompatible graft material (e.g., Dacron® or expanded,porous polytetrafluoroethylene (ePTFE)) supported by a framework (e.g.,one or more stent or stent-like structures), to treat or isolateaneurysms. The framework provides mechanical support and the graftmaterial or liner provides a blood barrier.

A side branch 3 may be laterally extendable and/or collapsible, i.e.expandable in a direction of a longitudinal axis along the side branch3, which direction is preferably substantially perpendicular to alongitudinal axis along a main body 2 of a stent-graft prosthesis 1.Alternatively, or in addition, the side branch 3 may be expandable in atransverse direction, i.e. expandable transverse to the direction of anaxis along the side branch 3. The side branch 3 may comprise astent-graft prosthesis and may in some examples be a covered stent.

In examples, the side branch 3 is about 1 cm to 1.5 cm laterallyextendable.

The side branch 3 is in an example integral with the main body 2, eitherby the stent-graft prosthesis of the main body 2 and the stent-graftprosthesis of the side branch 3 being integral, or by the cover of themain body 2 and the cover of the side branch 3 being integral. In anexample both cover and stent-graft prosthesis of the main body 2 isintegral with the cover and stent-graft prosthesis of the side branch 3.When the side branch 3 comprises the stent-graft prosthesis it isstiffer and can then resist more handling when e.g. deploying and/orre-deploying any further covered extension stent-graft prosthesis. Thisalso allows for the side branch 3 to form a tighter connection with anyfurther covered extension stent-graft prosthesis out from the sidebranch 3.

Additionally, this allows for using a stent-graft prosthesis or aplurality of stent-graft prostheses in a system and assembly at theimplantation target site, i.e. not pre-manufactured for a specificpatient. This is an advantage over known systems. Known systems includedhitherto pre-built, patient specific endoprosthesis. Usually, an imagemodality is used to scan the vessel system including the target site,e.g. a weakened aorta, earlier in time. The endoprosthesis is thenmanufactured based on the imaging data and delivered to the surgeon forimplantation. This manufacturing of a patient specific endoprosthesisusually takes days to weeks, which is undesired. The anatomy of thevessel may change during this waiting time. The consequence may be thatthe manufactured endoprosthesis does not fit the patient anymore. Also,the waiting time is undesired as the patient mostly is in immediate needof the endoprosthesis, e.g. to avoid rupture of an aortic aneurysm. Ifdesired, however, specific embodiments of the stent-graft prostheses ofthe present disclosure may be manufactured patient specifically. Astandard setup of different sizes readily available for implantation ispreferred, though, as waiting time due to manufacturing is avoided.

It should be emphasized that the term “comprises/comprising” when usedin this specification is taken to specify the presence of statedfeatures, integers, steps or components but does not preclude thepresence or addition of one or more other features, integers, steps,components or groups thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which examples ofthe disclosure are capable of will be apparent and elucidated from thefollowing description of examples of the present disclosure, referencebeing made to the accompanying drawings, in which

FIG. 1 is a schematic illustration of a stent-graft prosthesis with aside branch;

FIG. 2 is a schematic illustration of a stent-graft prosthesis with aside branch and a guiding element;

FIG. 3 is a schematic illustration of a stent-graft prosthesis with aguidewire arranged therein and an example of an orifice element for aguiding element;

FIG. 4 is a schematic illustration of a stent-graft prosthesis partlydelivered in an overlapping manner before expansion and fixation;

FIG. 5 is a schematic illustration of a stent-graft prosthesis deliveredin an overlapping manner:

FIG. 6 is a schematic illustration of a stent-graft prosthesis with aside branch, and a catheter with a guiding mate for guiding the catheterfor easy navigation of the side branch;

FIG. 7 is a schematic illustration of a stent-graft prosthesis beforeand after the stent-graft prosthesis is fully expanded;

FIG. 8 is a schematic illustration of a stent-graft prosthesis withthree legs, and a navigation element and a suture for easy navigation toall three legs;

FIG. 9 is a schematic illustration that shows a system of differentstent-graft prosthesis modules for implantation inside the aortic archand thoracic aorta of a patient;

FIG. 10 is a schematic illustration that shows the system of FIG. 9 whenit has been implanted inside the aorta of a patient;

FIG. 11 is a flow chart of an example of a medical procedure; and

FIG. 12 is a flow chart of an example of a manufacturing method.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Specific examples of the disclosure will now be described with referenceto the accompanying drawings. This disclosure may, however, be embodiedin many different forms and should not be construed as limited to theexamples set forth herein; rather, these examples are provided so thatthis disclosure will be thorough and complete, and will fully convey thescope of the disclosure to those skilled in the art. The terminologyused in the detailed description of the examples illustrated in theaccompanying drawings is not intended to be limiting of the disclosure.In the drawings, like numbers refer to like elements.

The following description focuses on an example of the presentdisclosure applicable to a medical device and in particular to a medicaldevice for facilitating navigation of and assembling of a stent-graftprosthesis or a plurality of stent-graft prostheses in communicationwith at least a side branch vessel. The implant can be used fortreatment and/or repair of vascular disease, such as e.g. aneurysm. Theexample is illustrated with an arrangement in the aorta. The vessel likethe aorta may be structurally damaged of different reasons and needrepair along at least a portion of the aorta 500. Sometimes extensiveendoprosthesis are needed for aortic repair, partly or all the way fromthe ascending aorta 501 via the aortic arch 502 down the descendingaorta 503 and along the abdominal aorta 504 past the renal arteries 505.

FIG. 1 is a schematic illustration of a stent-graft prosthesis 1 with aside branch 3. FIG. 2 is a schematic illustration of a stent-graftprosthesis with a side branch 3 and a guiding element 10.

FIG. 3 is a schematic illustration of a stent-graft prosthesis 600 witha guidewire arranged therein and an example of an orifice element 610for a guiding element 10. The distal end portion is enlarged in part Aof FIG. 3. Part B of FIG. 3 shows the prosthesis 600 collapsed (catheterand/or restraining member not shown) with the guiding element 10 easilyinsertable through a orifice element 610, here in an example including atube 620. FIG. 4 is a schematic illustration of the stent-graftprosthesis 600 partly delivered in an overlapping manner beforeexpansion and fixation. FIG. 5 is a schematic illustration of thestent-graft prosthesis 600 delivered in an overlapping manner. FIG. 7 isa similar schematic illustration of a stent-graft prosthesis 600 beforeand after the stent-graft prosthesis 600 is fully expanded;

The prosthesis 600 may include a body having a generally tubular wallstructure 605. The wall structure 605 preferably includes an orificeelement 610 for receiving a guiding element 10.

The prosthesis 600, in particular its wall structure, may have anoverlap region 630 for interconnection to another stent-graftprosthesis. The orifice element 610 is then preferably arranged at theoverlap region 630. The overlap region 630 is preferably arranged at aproximal end region of the prosthesis body.

The guiding element 10 is elongate and suitable to extend through bloodvessels and to be distally attached or connected to the body. Preferablyit is a textile thread or suture thread, optionally with a radiopaquemarker, such as a fiducial marker and/or a radiopaque elongate markerextending at least along a portion of a length of the guiding element10.

The orifice element 610 may be an aperture in the tubular wallstructure. The aperture is preferably an eyelet in a wall material ofthe wall and preferably has a reinforced periphery edge or a reinforcedperipheral region such as in the wall material adjacent the eyelet. Theorifice element 610 may be a side opening or aperture in the wallstructure, such as shown in the Figures.

The tubular wall structure has an outside. The orifice element 610 mayin examples be arranged at the outside of the wall. The orifice element610 may be an eyelet or a tubular element for receiving the guidingelement 10 at the outside of the wall. It may be arranged at the outsideonly, such that it does not comprise a through going hole or aperture inthe wall structure.

The tubular wall structure has an inside. The orifice element 610 may inexamples be arranged at the inside of the wall. For instance the orificeelement 610 may include an elongate such as tubular structure 620(example in FIG. 3) for receiving the guiding element 10. The elongatestructure may be arranged at the inside of the wall proximally andoriented towards an aperture in the wall. The guiding element 10 maythen be arranged through the aperture and the tubular structure. It mayadditionally include an orifice element at the outside of the wallstructure for guiding the guiding element 10, like an eyelet or opensock type element.t

Alternatively or in addition to tubular structure(s) outside and/orinside the tubular wall structure, multiple eyelet, flap, skirt, fold oropen sock type structures for receiving a guiding element 10 therethrough like a guiding mate. Multiple orifice elements may be providedat a suitable distance from each other and along a suitable length toreceive the guiding element through the eyelet structures along thelength. The eyelet, flap or open sock structures may be circular, ovalor have other suitable cross sections.

The tubular structure 620, like a tube or catheter of desired length maybe pre-arranged in a collapsed prosthesis 600, e.g. collapsed and keptin that collapsed state in a removable restraining member (not shown).The tubular structure extending through the opening in the wallstructure 605 allows to position the guiding element through the openingin an advantageous manner when the prosthesis is collapsed and to beentered (or being positioned in) a catheter. In case the prosthesis isalready in a catheter for delivery, the tube 620 may extend proximallyall the way through the catheter to its proximal end so that the guidingelement 10 can be threaded through the tube from its distal end/opening.The tube is a place-maker for the guiding element 10 to be easilypositioned through the orifice element 610. The tubular element 620 maybe part of the orifice element 610. The tube may also be short, justextending out of the proximal orifice of the prosthesis 600, such asshown in FIG. 3 at A and B. The tube 620 is preferably removable uponexpansion/implantation of the prosthesis 600 in position in andconnected overlappingly to the first prosthesis 1. The orifice element610 may be arranged at a rotational position of the tubular wallstructure for facilitating a rotational position of the body upondelivery. Thus, when the prosthesis 600 is advanced over the guidingelement 10 (and maybe additionally along a guidewire 20 extendingfurther distally than the distal end of the guiding element 10 at theconnection point 11). Guiding element 10 will at the connection point 11provide a stop for further advancing the prosthesis 600. Thus a reliableposition of the prosthesis is provided in relation to the otherprosthesis having the guiding element distally attached thereto.

The orifice element 610 is arranged like a guiding mate in theprosthesis for receiving a guiding element 10 there through. The distalend of the guiding element 10 is arranged at a connection point 11 at afirst prosthesis. Advancing the prosthesis 600 over the guiding element10 arranged through the orifice element 610 until it distally stops,provides a defined distal position of the prosthesis 10 during deliveryand implantation in relation to the first prosthesis. The orificeelement 610 shown in the Figures is merely an example.

The orifice element 610 is in examples a guiding mate. The guiding mateis configured for receiving the guiding element, such that thestent-graft prosthesis is configured to slide along the guiding element10 during delivery over the guiding mate 9 to the orifice of the firststent-graft to be connected to the second stent-graft, such as of thebranch.

Delivery and deployment of the stent-graft prosthesis is done through adelivery lumen of a catheter. FIG. 6 is a schematic illustration of astent-graft prosthesis with a side branch, and a catheter with a guidingmate for guiding the catheter for easy navigation of the side branch;

The guiding mate in form of an orifice element of a prosthesis is forreceiving the guiding element. The guiding element preferably has adistal end positioned proximally at a distance from, preferably adistal, orifice of a first prosthesis at a connection point, such as ofthe side branch. In this manner the stent-graft prosthesis 600preferably extends distally beyond the connection point when the orificeelement 610 (guiding mate) engages the connection point.

The guiding element 10 is preferably made of a biodegradable material.

The guiding element 10 may alternatively even be non-biodegradable butbiocompatible so that it safely can remain in the body (or be removedafter use).

The guiding element 10 may alternatively to a suture or thread be astiffer elongate element like a wire, e.g. of thermoplastic, metal orcoated metal. A stiffer wire has the advantage that it avoids buildup ofa knot or muddle of the guiding element when a prosthesis (and/orcatheter) is threaded along it. A stiffer elongate element is preferablyremovable arranged from the body after use.

A guiding element 10 in form of a wire may be provided with similar orsubstantially identical flexibility properties as a guidewire 20 used todeliver the prosthesis 600. This is in particular advantageous as boththe guidewire 20 and the wire 10 may be used to pull/push the prosthesis600 along both wires during delivery.

A reliable and stable delivery with precision positioning is providedwhile X-ray dosage is reduced as X-ray is not needed or substantiallyreduced to find the right overlap position for expansion of theprosthesis 600 at implantation. Also, a wire generally has less risk torupture during the delivery procedure.

A kit is provided in an example including a first stent prosthesis 1preferably having a lateral branch and a second stent-graft prosthesis600 described herein. The first stent prosthesis 1 has an orifice foroverlappingly connecting second stent-graft prosthesis 600 to it.

It should be noted that the second stent prosthesis 600 may have furtherbranches, possibly with own guiding elements for connecting furtherstent-graft prosthesis 600 to branches of it. Alternatively, or inaddition, the stent-graft prosthesis 600 may have guiding element 10 ata connection point affixed to it for connecting stent-graft prosthesis600. For instance the distal end of the stent-graft prosthesis 600 maycomprise the connection point 11 while for instance a proximal endthereof includes the orifice element.

The first stent-graft prosthesis may in a more detailed example have atleast one bendable and/or flexible guiding element 10 being distallypermanently or releasably attached to an interior of the firststent-graft prosthesis at a distance from an orifice thereof. Theguiding element 10 may be distally permanently or releasably attached toat least at one of the branches and at a distance from a distal orificeof the branch.

Aspects of the disclosure include, a system including the kit of theafore description. The guiding element 10 is preferably proximallyextending through the orifice element 610 for guiding the stent-graftprosthesis to a lateral branch 3 towards the distal orifice of thebranch 3 during delivery. In this manner, the stent-graft prosthesis isupon delivery arranged with a proximal overlap in the lateral branch.

FIG. 12 is a flow chart of an example of a manufacturing method 900. Themethod 900 includes providing 910 a generally tubular wall structure ofa prosthesis, and providing 920 the wall structure with an orificeelement 610 for receiving a guiding element 10. Suitable methods forperforming the steps will be known for the skilled person.

Aspects of the disclosure include, a method of delivery a stent-graftprosthesis. The method may include delivering a first stent-graftprosthesis having a side branch 3 in a vascular structure. The firststent-graft prosthesis having a guiding element distally permanently orreleasably attached to an interior of the at least one the branches 3 ata distance from a distal orifice of the branch 3. During delivery, thesecond stent-graft prosthesis is moved along the guiding elementarranged through an orifice element 610 of the second stent-graftprosthesis. The second stent-graft prosthesis is thus expanded with aproximal overlap in the side branch 3 when the orifice element 610 stopsagainst a distal end of the guiding element 10.

The stent-graft prostheses discussed herein are in an exampleself-expanding, or in another example expandable by another device, suchas an inflatable balloon.

Some examples of the disclosure provide for an improved navigation ofand assembling of a stent-graft prosthesis or a plurality of stent-graftprostheses. The stents to be assembled are to provide fluidcommunication upon delivery and assembly. For instance, a stent-graftprosthesis may be advantageously positioned in a side branch vessel froma main vessel. Fluid communication may be provided from a firststent-graft prosthesis in the main vessel to a second stent-graftprosthesis in such side vessel. Fluid communication may also be providedin other configurations requiring overlapping assembly of a plurality ofmodular stent-graft prostheses.

By stent-graft prosthesis means a stent or stent-graft having an innerand/or outer liner, shell or being otherwise surrounded by or providedwith a liquid impermeable fabric or material. The covered stent can bepartly or fully covered. A covered stent can also be called a stentgraft or an endoprosthesis. Generally these stent-graft prostheses aretubular prostheses. The tubular prosthesis such as stents, grafts, andstent-grafts (e.g., stents having an inner and/or outer coveringcomprising graft material and which may be referred to as stent-graftprostheses) have been widely used in treating abnormalities inpassageways in the human body. In vascular applications, these devicesoften are used to replace or bypass occluded, diseased or damaged bloodvessels such as stenotic or aneurysmal vessels. For example, it is wellknown to use stent-grafts, which comprise biocompatible graft material(e.g., Dacron® or expanded, porous polytetrafluoroethylene (ePTFE))supported by a framework (e.g., one or more stent or stent-likestructures), to treat or isolate aneurysms. The framework providesmechanical support and the graft material or liner provides a bloodbarrier.

A side branch 3 may be laterally extendable and/or collapsible, i.e.expandable in a direction of a longitudinal axis along the side branch3, which direction is preferably substantially perpendicular to alongitudinal axis along a main body 2 of a stent-graft prosthesis 1.Alternatively, or in addition, the side branch 3 may be expandable in atransverse direction, i.e. expandable transverse to the direction of anaxis along the side branch 3. The side branch 3 may comprise astent-graft prosthesis and may in some examples be a stent-graftprosthesis.

In examples, the side branch 3 is about 1 cm to 1.5 cm laterallyextendable.

The side branch 3 is in an example integral with the main body 2, eitherby the stent-graft prosthesis of the main body 2 and the stent-graftprosthesis of the side branch 3 being integral, or by the cover of themain body 2 and the cover of the side branch 3 being integral. In anexample both cover and stent-graft prosthesis of the main body 2 isintegral with the cover and stent-graft prosthesis of the side branch 3.When the side branch 3 comprises the stent-graft prosthesis it isstiffer and can then resist more handling when e.g. deploying and/orre-deploying any further covered extension stent-graft prosthesis. Thisalso allows for the side branch 3 to form a tighter connection with anyfurther covered extension stent-graft prosthesis out from the sidebranch 3.

In an example, the stent-graft prostheses have a substantially identicaldiameter at an inter-connection between two stent-graft prostheses toprovide a liquid tight interconnection.

In an example, having the same diameter at an inter-connection meansthat the outer diameter at the inter-connection of one of thestent-graft prostheses is substantially the same as the inner diameterat the inter-connection of the other stent-graft prosthesis, at leastalong a portion of the stent-graft prosthesis. The same diameter ismaintained at least along an overlapping portion of the two stent-graftprostheses, if overlapping. The two stent-graft prostheses are thus forinstance liquid conveying connectable by overlapping each other and onetube inside the other connected tube.

The stent structure of stent-graft prostheses is part of the stent-graftprosthesis. It may have a pattern, like undulations. The pattern (suchas schematically shown in e.g. FIGS. 3-5 and 7) may be made by made bybraiding, weaving, laser cutting of a tube, etc. The structure is ascaffold to support the structure outwards and provide a substantiallytubular structure to ensure undisturbed blood flow through the tube whenimplanted as it is provided with and covered by a suitable liquid tightcover.

The undulations or pattern can be denser at the overlapping connectionregion than other regions of the stent-graft prosthesis—for a secureliquid tight connection of two stent-graft prostheses and by improvedmechanical strength.

In an example the two stent-graft prostheses to be interconnected haveboth substantially the same inner diameter and substantially the sameouter diameter at the interconnection, and the stent-graft prosthesesare connected by overlapping them when one of the stent-graft prosthesesis in a partially collapsed or folded state.

Having stent-graft prostheses with the same or substantially the samediameter makes it easy for the operator to connect the variousstent-graft prostheses since the diameter of corresponding stent-graftprosthesis parts of the system 100 is similar and the operator does thennot need to worry about any particular connection method, stent shape,connection site or the like. This means that the operator does only needto consider if the previous stent-graft prosthesis were a single,double, triple or further legged stent-graft prosthesis. This also makesthe production of the stent-graft prostheses easier since the diameterat the connection of the various stent-graft prostheses are the same. Anexample is the diameter of legs 202, 203, stent-graft prosthesis 300main body, and upstream oriented legs of the stent-graft prosthesis 400.

The overlapping region allows for length adaptation of the modularsystem. For instance the modular stent-graft prostheses, 400, 410, 420could be provided as a single integral unit. However, providing straightmiddle piece stent-graft prosthesis 410 separate from branched end piecestent-graft prostheses 400, 420, allows for adjustment to specificpatient anatomy (in the example different length of abdominal aorta).Overlap of the middle stent-graft prosthesis can be varied accordingly.Length adjustment of a system of modular stent-graft prostheses isprovided by an overlapping portion at openings of stent-graft prosthesesallowing for varying overlap and determining total length of theassembled modular system upon implantation. This applies, mutatismutandis to side vessel extension stent-graft prostheses 600connections, etc.

Providing the stent-graft prostheses 1 with substantially the samediameter gives the advantage that the operator can implant eachstent-graft prosthesis 1 as explained above, or in an example in anydirection he or she thinks is best. This will shorten the time requiredfor assembling the system 100 and consequently the operation,drastically.

In an example, when the stent-graft prosthesis 1 has substantially thesame diameter as discussed above and is expanded, or when a side branch3 or leg of the stent-graft prosthesis 1 is expanded, a flow through thestent-graft prosthesis 1 is more or less unchanged through it. Meaningthat a liquid, such as blood, entering at one side e.g. the main body 2will pass through the stent-graft prosthesis 1 and out through e.g. twolegs at the other side and due to the expansion and same diameter ofconnection at the stent-graft prostheses 1 an inlet and outlet area aresubstantially the same. This allows the operator to concentrate onconnecting one stent-graft prosthesis 1 or part of a stent-graftprosthesis 1, such as a leg, at the time. The operator needs not toworry about the stent-graft prosthesis 1 disturbing the flow orthroughput in the stent-graft prosthesis 1 or vessel. Use of orificeelements 610 and guiding elements 10 contributes likewise thisadvantage.

The modular stent-graft prosthesis system 100 further comprise one ormore guiding element(s) 10, like a suture or wire. Along guiding element10 a delivery catheter may be threaded proximally to the distal end ofthe guiding element 10. The guiding element 10 is distally affixed to astent-graft prosthesis, for instance a suture may be affixed by means ofa knot, staple, weld, adhesive, or similar. The guiding element 10 isthus secured to the stent-graft prosthesis. Preferably, the attachmentpoint where the guiding element 10 is distally secured to thestent-graft prosthesis is at the interior, e.g. at a location of alateral side branch of the stent-graft prosthesis. The guiding element10 is preferably pre-loaded in a delivery catheter of the stent-graftprosthesis. The guiding element is in use operating as a guilder for aguiding mate 9 of a catheter. The guiding element 10 is preferablybendable and/or flexible.

In embodiments, the guiding element 10 is thus distally permanently orreleasably attached to an interior of a branch, e.g. a lateral sidebranch, at a connection point, preferably at a distal orifice of thebranch 3. The guiding element 10 is proximally arranged in the interior,through and along a proximal portion of the main body 2 or another ofthe branches 3 and extending proximally through a proximal opening ofthe main body 2 (see e.g. FIG. 3 or 8). In use the guiding element isthus operating for guiding a catheter over the guiding element 10through the main body 3 towards the distal orifice of the lateral sidebranch 3.

See FIGS. 2 to 8 and the corresponding text herein for more detaileddescribed examples of the guiding element 10 and its corresponding useand application in a modular stent graft system.

Alternatively, or in addition, a guiding element 10 can be distallyattached to a vessel wall or an organ at a target location. It may forinstance be attached to the wall of the aorta of a patient at a desiredtarget location for a prosthesis having an orifice element for delivery.Delivery is performed in a similar manner as to a first stent-graftprosthesis having a connection point 11 with the difference that theconnection point 11 is at the anatomical target location. The distal endof the guiding element is thus configured to be anchored at a tissuelocation. Anchoring may be provided by suitable anchoring means orunit(s) like barbs, staples, knotted sutures, etc.

Alternatively, or in addition, the attachment of a guiding element atits distal end may be releasable, preferably releasable from outside thebody activation, for removing the guiding element during theimplantation procedure, as needed. A knot may be releasable, thermaldetachment means may be provided for controlled detachment of theguiding element at the attachment point. Alternatively, or in addition,the guiding element may be configured to be cut off after use. Suitabletools may be used for the cutting off, e.g. a sheath with an interiorsecure cutter slid over and along the guiding element towards theattachment point, where the cutter is activated and the guiding elementcut off. The guiding element may then be securely retracted out of thebody, e.g. within the sheath having the cutter, or just proximally drawnout of the vasculature via the puncture site/introducer.

However, the guiding element 10 is in examples configured to be left inplace upon concluded implantation procedure. The guiding element 10 canthus be left in place after use (guiding delivery and deployment of e.g.an extension stent graft) or removed. It may be made of a biodegradablematerial or bioabsorbable material. The guiding element 10 is in anycase made of a biocompatible material, including absorbables such aspolyglycolic acid, polylactic acid, Monocryl and polydioxanone as wellas the non-absorbables nylon, polyester, PVDF and polypropylene, PTFE orDacron. The guiding element 10 may be made of metallic material, such asNitinol or stainless steel, or a suitable metal alloy, which might beadvantageous from a durability advantage during implantation. This maybe advantageous during delivery as described above and also when theguiding element is left in place after concluded implantation procedureof the modular stent-graft prosthesis system. The procedure can beshortened as the guiding element needs not necessarily to be detached orcut off at or close to the connection point. It may be cut of at isproximal end only, or not at all.

Along guiding element 10, alternatively or in addition to stent-graftprosthesis 600 having an orifice element, a delivery catheter 30 may bemoved towards the distal end of the guiding element 10, e.g. by means ofa guiding mate 9 on the catheter as described herein (FIG. 6). Deliveryof another element, device or unit, can then take place through thisdelivery catheter to a desired site at the distal end of the guidingelement 10. X-Ray guidance, probing, navigation tries etc. canadvantageously be reduced or omitted.

In this manner, a catheter can be moved along the guiding element to ortowards the distal end thereof without fluoroscopic guidance. In thismanner, reliably, and speed of delivery is improved while radiationexposure can be reduced.

Such a delivery catheter 30 is provided for delivery of an extensionstent graft 600. The catheter 30 has a delivery lumen with a distalorifice for delivery and deployment of the extension stent graft 600 ata target site of a lateral side branch 3 of a stent-graft prosthesis 1.

The catheter 30 further has a guiding mate 9 for receiving a guidingelement 10 distally attached to a connection point at the branch 3.Therefore, the catheter 30 is configured to slide along the guidingelement 10 over the guiding mate 9 to the orifice of the branch fordeployment of the element, such as the extension stent graft 600 throughthe delivery lumen of the catheter.

The guiding mate 9 for receiving the guiding element has a distal endpositioned proximally at a distance from the distal orifice of thedelivery lumen. In this manner the delivery lumen extends beyond theconnection point when the guiding mate 9 distal end engages theconnection point.

As can be seen e.g. in FIG. 6, the distal end of the delivery catheter30 may be pre-bent to advantageously enter into the side vessel from thebranch orifice. In this manner the operation time is reduced,fluoroscopic load of the patient and clinical personnel reduced, and theimplantation made more securely and reliable.

A guidewire may thus be deployed in a side branch 3 through the catheter30. Catheter 30 may then be withdrawn, the guidewire left in place.Stent-graft prosthesis may then be advanced into the side branch (seeFIG. 4 at A and B). Upon expansion (FIG. 5) the guidewire 20 is removed.

A modular stent graft system is provided including a stent-graftprosthesis 1 and a delivery catheter 30 with a guiding element 10arrangeable or arranged through a guiding mate 9. In this manner a unit,such as an extension stent graft 600 is advantageously deliverablethrough the delivery catheter 30 to a target site at a branch 3.

In addition, the distal end of the guiding element 10 is for examplearranged at a marker 21. Alternatively, or in addition, the guidingelement 10 may be provided itself with a marker. Marker means fiducialmarker that is visualizable by suitable imaging means for the surgeonperforming the implantation procedure. The marker 21 is preferablyarranged at a leg 4 of a stent-graft prosthesis for guiding delivery ofanother stent-graft prosthesis towards and/or through the distal orificeof such a leg 4, e.g. as described below, to a side branch vessel of amain vessel. The marker may be elongate and extend along at least a partof the length of the guiding element 10, e.g. as a radiopaque strand ofa multi-strand wire/suture/thread, and/or one or more marker bands.

The illustrated modular stent-graft prosthesis system 100 includes afirst main vessel stent-graft prosthesis 200, 420 with a first upstreaminlet branched into at least two downstream outlet branches.

Further it includes a stent-graft prosthesis type 300, 310, 320 that hasa main body, and at least one lateral side branch connected to the mainbody. The lateral side branch is preferably flexible and expandable. Thestent-graft prosthesis is interconnectable to one of the downstreamoutlet branches and laterally connectable to a side stream vessel of themain vessel via the lateral side branch thereof. At least twostent-graft prostheses 300, 310, 320 are thus sequentiallyinterconnectable to one of the downstream outlets of the main vesselstent-graft prosthesis 200. In this manner, blood conduits are providedarranged in parallel by the at least two stent-graft prostheses, one ata time assembled by the operator. The parallel blood conduits may beprovided with one or more side branches each. Alternatively, or inaddition, a blood conduit in form of a stent-graft prosthesis may beprovided that has no lateral side branch, which then provides a straightblood flow path in parallel with e.g. a stent-graft prosthesis havingone or more lateral side branches.

The modular stent-graft prosthesis system further includes a second typeof main vessel stent-graft prosthesis 400, 430 with at least twoupstream inlet branches collected in a downstream outlet. The inletbranches are interconnectable to a distal outlet of one of the twostent-graft prostheses, e.g. stent-graft prostheses type 300, 310, 320as shown in FIGS. 9 and 10.

Starting from the top of the system 100 as illustrated in FIGS. 9 and10, there is illustrated a first stent-graft prosthesis 200 with threelegs. This module is implanted firstly over a guidewire 20.

It should be noted that the stent-graft prosthesis modules are deliveredin a specific order, starting with a three-legged stent-graft prosthesis200 in the ascending aortic arch. Further stent-graft prosthesis modulesare then delivered to the target site until the entire system isimplanted. This is done in a very efficient and advantageous manner.

For instance, when the three legged stent-graft prosthesis 200 isdeployed and implanted firstly of all modules in the ascending aorticarch. This can be done via a guide wire 20, e.g. in a femoral accessapproach. Further components can then be connected to the legs 201, 202,and/or 203.

For instance a stent-graft prosthesis 600 can be delivered to the firstleg 201 via a delivery catheter slid along guiding element 10 to ortowards connection point 11, such as in the manner described withreference to FIGS. 1 to 5-. This stent-graft prosthesis 600 can thenextend blood flow e.g. into the first neck side vessel as shown in FIG.10. The stent-graft prosthesis 600 is a stent-graft prosthesis withoutapertures for side vessels. The extension stent graft 600 is configuredto be proximally matingly and fluid tight connected to the distalportion at the orifice of the first leg 201. Connection may be doneoverlappingly in a suitable manner and by suitable means known in theart of connecting stent grafts to each other for providing acommunication channel for liquid there through to the target vessel.

Delivery is thus provideable in two steps. Firstly, the side branch 3 isexpanded. Then a side vessel stent-graft prosthesis 600 is deployedthrough the expanded side branch 3, preferably along a guiding elementand mating orifice element 610 for desired overlap. Fixation of the sidevessel stent-graft prosthesis 600 is done then (FIG. 5 or 7). The entireprosthesis is flexible until the side branch is finally intubated, i.e.the side branch stent-graft prosthesis 600 is deployed and thus “locked”in position.

During delivery of stent-graft prosthesis 600, the two remaining legs202, 203 are not obstructed and blood flow through the aortic arch isensured during the implantation procedure, which is an importantadvantage.

The guiding element 10 is also running inside the third leg 203. Thismeans, that over same guiding element 10 and delivery catheter overwhich the stent-graft prosthesis 600 was delivered, the stent-graftprosthesis 300 with a side branch is deliverable.

The initial guidewire 20 for delivering the three-legged stent-graftprosthesis 200 to its target site, is used for delivering and connectinga stent-graft prosthesis 300 to the second leg 202.

The location of three-legged stent-graft prosthesis 200 is preferablymarked with a fiducial marker 21 that can be seen during imaging by e.g.MRI, CT or X-ray. Hence, shortened radiation times and dosages areprovideable.

As the guiding element 10 extends out from the first leg 201, all threelegs can be located and modular stent-graft prostheses interconnected atthe orifices of the three legs. No additional navigation, searching orprobing by the surgeon is needed, thus reducing radiation times anddosages.

The guiding elements 10 are for guiding subsequent stent-graftprostheses along them so that the subsequent stent-graft prostheses canbe connected to a previously implanted stent-graft prosthesis.

In addition, or alternatively a navigation element 20, such as a guidewire, is used instead for or together with one or more guidingelement(s) 10 in the system 100 for guiding all or almost all of thestent-graft prostheses of the system 100 to their target site.

Next, the system 100 includes in proximal direction, downstream theaorta, two stent-graft prostheses 300 with one side branch each,positioned in the aortic arch 502 upon implantation. The two stent-graftprostheses 300 may include orifice elements 610 and are each guided bythe guiding elements 10 and guidewire 20, respectively.

The side branch exit is preferably expandable, and in liquidcommunication with a neck vessel when expanded. A further stent-graftprosthesis 600 is further connected with its proximal end, respectively,extending into the remaining two neck vessels respectively (see FIG.10). Delivery of these further stent-graft prostheses 600 can be donefiducial marker guided (not shown), with guidewires and contrast mediumfeedback, and/or a guiding element 10 can be connected to the branch(see FIGS. 1 to 5 and 7) facilitating delivery of the furtherstent-graft prostheses 600 through the orifice of the side branch ofstent-graft prosthesis 300 and into the respectively neck vessel.

As the orifices of the lateral branches can be located at a distancefrom the ostia of a target site vessel thanks to the parallelarrangement of several stent-graft prostheses 300, the exact position inrelation to each other (ostia/orifice) is not as important as for knownstent-graft prostheses. Flexibility without risk for kinking is providedin particular with extension stent-graft prostheses 600.

Then, downstream the aorta there is proximally a stent-graft prosthesis400 with two distal legs united into a single lumen body having aproximal orifice. The first leg of stent-graft prosthesis 400 isdelivered running along guiding element 10 for interconnection with theproximal orifice of the stent-graft prosthesis 300, which in turn ispreviously distally interconnected to the third leg 203 of the distallyand upstream in the aorta arranged and previously implanted stent-graftprostheses 300. The other distal leg of stent-graft prosthesis 400 isdelivered along guidewire 20. It is distally interconnected to theproximal orifice of the other stent-graft prosthesis 300, which in turnis previously distally interconnected to the second leg 202 of thedistally and upstream in the aorta. Thus the parallel stent-graftprostheses 300 are collected together in a single lumen.

A further stent-graft prosthesis 410, without side branches or legs isdistally interconnected to the proximal orifice of stent-graftprosthesis 400. The further stent-graft prosthesis 410 is delivered overboth the guiding element 10 and guidewire 20 which both are run insidethis stent-graft prosthesis 410 through one of the distal legs ofstent-graft prosthesis 400 respectively. In case the stent-graftprostheses 300 include one or more guiding element(s) 10, previouslyused for the extension stent-graft prostheses into the neck vessels,these one or more guiding element(s) 10 will also be run through thelumen of stent-graft prosthesis 410.

Overlap of stent-graft prostheses, such as 400, 410, 420, can be adaptedduring implantation to accommodate the patient aortic anatomy. Orificeelement(s) 610 facilitate finding of a suitable overlap position beforeexpansion/release of the stent-graft-prosthesis 600.

Next in downstream aorta direction is a two-legged stent-graftprosthesis 420 is implanted/provided and branching the blood flow intotwo proximal legs from a distal common lumen and orificeinterconnectable to proximal orifice of the distal stent-graftprosthesis 410 previously implanted. Guiding element 10 runs inside thefirst leg. Guidewire 20 runs inside the other leg. The two legged stentis delivered over the two latter in a delivery catheter, which may bethe same as used for delivery of previously distally delivered modules.

And finally, at the bottom of the drawing, two stent-graft prostheses310, 320 are illustrated, with two side branches 3 each.

The first stent-graft prosthesis 310 is delivered by means of guidingelement 10 (catheter slid over guiding element 8 to the leg ofstent-graft prosthesis 420). A further delivery catheter may be used forthis purpose, where the guiding element runs all the way through thefirst stent-graft prosthesis 310. One or more further guiding element(s)10 may be attached to one or more of the side branches of the firststent-graft prosthesis 310 for delivery of extension stent-graftprostheses 600 extending into side vessels, see FIG. 10 when implanted.

The second stent-graft prosthesis 320 is delivered by means of guidewire20. A delivery catheter is again used for this purpose, such asdescribed above. A further guiding element 10 may be attached to one ormore of the side branches of the second stent-graft prosthesis 320 fordelivery of extension stent-graft prostheses 600 extending into sidevessels, see FIG. 2 when implanted.

The proximal end of the two stent-graft prostheses 310, 320 areinterconnected to two distal legs of a two legged stent-graft prosthesis430 to provide a liquid path thereby. Guidewire 20 and guiding elements10 run accordingly through stent-graft prosthesis 430.

As described above, the system 100 is thus positioned as shown in FIG.10.

In an example a method of interconnecting a plurality of stent-graftprostheses is provided which can be performed either in vivo and/or invitro.

In an example, before assembly, and/or during assembly, the stent-graftprostheses of the system 100 are sorted and placed in the correct orderfor assembly. In an example, and if assembled during implantation, anumber of catheters 30 may be used as described and needed. Thecomponents of the system may be provided as a kit with suitablenumbering to facilitate implantation for the surgeon. The kit componentsand composition may be computer plant prior to the implantationprocedure. A software may be provided to support the surgeon and/orclinical personnel to perform the procedure. The surgeon may virtuallyplan the procedure in advance. Sequence of components, preferably withnumbers in the kit components, and procedural steps may then besuggested by software during the implantation procedure. Qualityassurance may be provided by entering into the software feedback ofcomponents used and steps performed. X-ray images and timestamps andother medical equipment measurement or input data may be saved too. Theprocedure may thus be efficiently performed and documented at the sametime.

Although not shown in FIG. 1, further navigation elements 20 and/orguiding elements 10 may be provided for navigation of the side branches3 and aligning of the side branches 3 with branch vessels, as explained.To make it easier to see which navigation element 20 or guiding element10 that goes to a certain stent-graft prosthesis, leg or side branch,each navigation element and guiding element is labelled in an example.

FIG. 8 illustrates a stent-graft prosthesis 200 with three legs 201,202, 203, and a navigation element 20 and guiding element 10 in from ofa suture for easy navigation to all three legs. FIG. 8 illustrates anexample of how one or more (one shown) guiding element 10, such as asuture, may run through a stent-graft prosthesis during implantation ofa system 100 of stent-graft prostheses.

The three legs 201, 202, 203 are provided for connection to three aorticarch side vessels: one into the neck artery, and two through channels(when assembled) with side branch vessel connection. The three legs 201,202, 203 may have different lumen diameter and length. The pre-attachedguiding element 10 extending into one leg (203) and into another leg(201) allows for a direct intubation of a side vessel. Direct access isprovided to all side branches of the prosthesis without the difficultyof locating the side branches with the open legs of such an implant.This has hitherto been difficult to navigate, due to the length of thedelivery catheter where the operator usually has no feeling fortargeting to a side vessel. Also the pulsating blood flow during theprocedure, and other procedural difficulties of intubation of sidebranches, are less relevant than for known stent-graft prosthesis. 3D to2D visualization difficulties are avoided, less x-ray dosage is needed,the procedure is provided with significant time reduction, and reducedpatient risk.

FIG. 8 further illustrates that one or more guiding elements 10, such assutures, may be attached to the stent-graft prosthesis 200. In thefigure, the suture 10 is attached inside the second leg 4 and extendsout through the third leg. The guiding elements 10 have, as discussedabove, a similar purpose to the purpose of the navigation element 20 ofguiding delivery catheters for delivery of stent-graft prostheses suchthat they can be connected to form the system of stent-graft prostheses100.

The operator can easily locate the two legs and navigate furtherstent-graft prostheses to any of the two legs. The operator can via theguiding element 10 navigate a first further stent-graft prosthesis 600to the leg 201 where the guiding element 10 is attached. When the firstfurther stent-graft prosthesis 600 is correctly positioned and connectedto the three-legged stent-graft prosthesis 200, the operator can, viathe same guiding element 10, navigate a second further stent-graftprosthesis to the leg 203 where the suture exits proximally from thethree legged stent-graft prosthesis 200. The navigation element 20ensures that the operator can locate also the third leg, as shown inFIG. 8, and deliver units that way as desired.

In an example as illustrated in FIG. 8, the navigation element 20, herea guide wire, runs inside and through the three legged stent-graftprosthesis 200 via a leg 202. During implantation of the system 100, thenavigation element 20 is inserted far enough into the vessel so that anystent-graft prosthesis can follow the navigation element 20 to a desiredtarget site location.

In an example, the stent-graft prostheses are guided to their respectiveposition by sliding them along a navigation element 20 inside a deliverycatheter. Upon release out of the distal catheter end, the stent-graftprostheses are expanded into place and implanted at that target site.Restraining members 8 may be provided.

Overlap with stent-graft prostheses 1, 300, 600 may be chosen accordingto patient anatomy during the implantation procedure. The connectionpoint 11 can be adjusted accordingly (to patient anatomy) when affixingthe guiding element 10 distally prior to implanting the prosthesis withthe connection point. Thus overlap is automatically adjusted to thespecific patient. Normally, a suitable overlap (position of connectionpoint 11 in relation to the orifice element position) will be based onaverage patient anatomies.

The guiding element 10 is used thus for guiding further stent-graftprostheses to a connection location so that the stent-graft prosthesescan be connected together into to the system 100 of stent-graftprostheses.

Generally, one advantage of using the guiding element 10, such a suture,instead of or in addition to the navigation element 20, such as aguidewire, is that a suture or a wire is provided flexible and can bebent and manipulated as desired without breaking. The navigation element20 when being a guidewire is in some examples stiffer such that it canexert a distal force from the operator for e.g. pushing along a vesselfrom a puncture site. A catheter is then thread over the guide wire andmoved along the guide wire. The guide wire may then be removed from thecatheter for delivery of a unit through the catheter.

The flexible characteristics of the guiding element 10 allows for e.g.the stent-graft prosthesis to be placed into positions and/or navigatedaround e.g. corners in the stent-graft prosthesis and/or in a vesseland/or side branch 3. The guiding element 10 runs in embodiments outsideof a delivery catheter lumen through which a unit is deliverable.Alternatively, or in addition, a guiding element may run through thesame lumen as the lumen for delivery of a unit.

Preferably the distal tip of the catheter 30 has a design such that thedistal orifice extends beyond the attachment point of the distal end ofthe guiding element 10. This can for instance be provided by alongitudinal recess (not shown) in the catheter lumen wall into whichthe guiding element 10 fits. The distal end of the catheter 30 with itsdelivery orifice may then protrude beyond the attachment point 11 wherethe proximal end of the recess will be positioned when the deliverycatheter 30 is pushed distally forward. The recess may be a longitudinalslit. The recess may have at least a V-shaped portion to allow theguiding element 10 to be caught or introduced more easily in the recess.The catheter 30 may be slightly wiggled and/or rotated to allow theguiding element 10 to enter the recess.

As explained previously in relation to guiding element 10, the position11 where the distal end of the guiding element 10 is permanently orreleasably attached to the stent-graft prosthesis is advantageouslyprovided with a marker, so that it can easily be seen during scanning bye.g. MRI, CT or X-ray. The connection point 11 serves as a stop unit forguiding element 10 to prevent a tangible resistance and further distaladvancement of catheter 30 by the surgeon during the delivery procedure.

FIGS. 1 and 2 illustrate a stent-graft prosthesis 1 with a side branchand is an example a stent-graft prosthesis 300 with a side branch 3 ofthe exemplary system 100 (FIGS. 9 and 10).

The stent-graft prosthesis 1 has a main body 2, which is a stent-graftprosthesis, and a lateral side branch 3 connected to the main body 2.The side branch 3 protrudes out from the main body 2 and is flexible andexpandable. One advantage of the side branch 3 being flexible andexpandable is that the side branch 3 is easily movable in at least onedimension independent of the movement of the main body 2 such that abranch vessel can be found and more easily aligned with duringimplantation to enter into with the side branch 3. Alternatively, or inaddition, the stent-graft prosthesis 1 has a plurality of legs andwherein at least one of the legs comprises a side branch 3. Thus, in anexample (not shown) the stent-graft prosthesis 1 has a plurality of legsand each leg comprises a side branch 3. In an example the side branch 3is deflated, collapsed or folded and may look like the side branch 3 ofFIG. 1. Collapsed may include radially and/or longitudinally collapsedstates, allowing reduced cross-section for delivery.

The stent-graft prosthesis 1 or side branch 3 may include wires that aresuitably arranged as a stent/supporting frame part of the stent-graftprosthesis. In an example the wires may have a U shape in a longitudinaldirection of the stent-graft prosthesis. In another example the wiresmay be helically wound.

In an example the wires may be wires interwoven with the covering. Thewires may form a mesh, like a knitted pattern or a braiding. The wiresmay also be laser cut to form the springy pattern of the stent part.

Alternatively, or in addition, the wires or other expansile componentsof the present device may be made of a shape memory material. The shapememory effect of such wires may provide for a change of shape, such ascollapsed to expanded shape, by means of known triggers liketemperature. Suitable materials include Nitinol, CrMo alloys, shapememory polymers, etc. Shapes of components of embodiments made of suchmaterials may be provided by heat treatment. Components of embodimentsof such materials may rely solely on elastic or superelastic properties(e.g. Nitinol) for a change of shape from a collapsed or compressedconfiguration to an expanded, released, configuration.

When the stent-graft prosthesis 1 is made in a resilient configuration,upon exiting a delivery catheter, it will resiliently expand out fromthe main body of the stent-graft prosthesis, as for instance describedbelow with reference to FIG. 3-5 or 7.

Alternatively, or in addition, the orifice element 610 like guiding mate9 comprises a ring, eyelet, snarl, or loop for threading through of theguiding element 10. An inner diameter of the orifice element 610 likeguiding mate 9 is matched to receive an outer diameter of the guidingelement 10 with some tolerance to avoid too much friction between thetwo elements for sliding motion along each other.

The orifice element 610 like guiding mate 9 is a unit for matinglyreceiving the guiding element 10 there through for being slidinglymovable along the orifice element 610 like guiding mate 9 to and fromthe guiding mate's distal end where it is preferably attached to astent-graft prosthesis. The guiding element 10 is configured to bethreaded through the orifice element 610 like guiding mate 9 for beingslidingly moveable along the guiding mate 9. Threading through of theguiding element 10 is suitably done outside of the patient at theproximal end of the guiding mate, e.g. a suture, thread, filament orwire, of e.g. multifilament strands, that are for instance braidedtogether, to form a flexible guiding unit 10. Alternatively, or inaddition, the guiding mate 9 can be a lumen of a dual (or multi) lumencatheter or any other suitable element which is configured to allowsliding on the guiding element 10 and preferably does not damage thevessel or lumen it is used in.

For easier alignment with a branch vessel, the stent-graft prosthesisside branch 3 can be provided with a marker 21. The marker 21 will makeit visible to the operator when the side branch 3 is level or alignedwith a branch vessel. By having only one marker at the side branch 3 itwill be easier for the operator to align the stent-graft prosthesis 1 toits desired location by use of an imaging device, such as X-ray, thantoday's stent-graft prostheses having a plurality of markers that needto be brought in alignment in fluoroscopy. The marker 21 is in examplesany fiducial marker visible under common type if imaging devices used inhealthcare or stent-graft prosthesis placement such as MRI, X-ray,Ultrasound, and so on. Stent-graft prosthesis structures usually arethemselves difficult to see under e.g. fluoroscopy. Markers may e.g.made of gold or similar materials allowing good visibility in suchimaging.

In an example, the side branch 3 is folded or collapsed and restrainedby a guiding element 10, such as a suture 10. The guiding element 10 isfor instance wrapped around the side branch 3, and is releasableconnected on the inside of the side branch 3 or otherwise attached tothe side branch 3 causing it to be releasably folded or collapsed.Pulling the guiding element proximally then releases the side branch 3from the collapsed state to the expanded state. Guiding element 10remains in place for use as a catheter guide and/or a prosthesis with anorifice element 610.

An example of a side branch prosthesis 300 implementation can be asfollows:

-   -   Length of prosthesis side branch 3 may be approx. 15 mm    -   Some other exemplary but not limiting measures are given in FIG.        7    -   The pre-load guiding element 10 feature:        -   It is secured with the side branch, preferably in a position            that assists to manipulate the orientation of the catheter            to matingly engage the guiding element 10. The connection            point is e.g. at the distally oriented inner side of the            branch 3 such that the guide catheter 30 can be            advantageously navigated through the lumen of the branch 3            towards a side vessel orifice or lumen.        -   The pre-load guiding element 10 works as a guilder for a            catheter 30, e.g. the double lumen catheter shown in FIG. 6            to reach the side vessel.        -   The pre-load guiding element 10 is preferably configured to            unlock from the prosthesis easily.

An example of a visceral side branch 310 can be as follows:

-   -   The prosthesis side branch 3 can be provided to maintain a        certain angel in relation to the main body 2 longitudinal axis,        e.g. approximately a 30-dgree angle or a 45-degree angle to        assist a surgeon to enter a side vessel with the catheter 30.    -   The inner diameter of a side branch may be in the range of about        7 mm,    -   The side branch prosthesis 3 is provided to allow a certain        level of movement to allow adjustment to various connection        angles towards side vessels.

FIG. 11 shows flow chart examples of a medical procedure.

The method 700 comprises the steps of accessing 710 a target site beinga vessel in a patient; delivering 720 a first stent-graft prosthesis tothe inside of the vessel at the target site through a delivery catheter,wherein the target site has a side branch vessel; delivering 730 asecond stent-graft prosthesis to the first stent-graft prosthesis;connecting 740 the first stent-graft prosthesis to the secondstent-graft prosthesis for providing a blood flow to the side branchvessel. The delivery of the second stent-graft prosthesis includessliding a catheter 30 along a guiding element 10 to a position inside alumen of a side branch of the first stent-graft prosthesis; delivering aguidewire to the side branch, removing the catheter 30, delivering andexpanding the second stent-graft prosthesis along guiding element 10 andalong orifice element 610 for connecting to the first stent-graftprosthesis. The catheter 30 with guiding mate 9 are thus in the methodused for the delivering of a guide wire. Once the guidewire is in placein the side branch and extends sufficiently long into the side vessel atthe side branch, the catheter 30 may be retracted. A covered extensionstent 600 can then be delivered over that guidewire to the side vessel,see e.g. FIG. 3-5 or 7.

Alternatively, or in addition, the method 800 is provided. The secondstent-graft prosthesis may have a side branch 3. The method includesdelivering a second stent-graft prosthesis to a side vessel through aside branch 3 of the first stent-graft prosthesis. The method 800comprises the steps of accessing 810 a target site being a vessel in apatient; delivering 820 a first stent-graft prosthesis to the inside ofthe vessel at the target site through a delivery catheter, wherein thetarget site has a side branch vessel; expanding 830 the side branch 3,delivering 840 a second stent-graft prosthesis to the first stent-graftprosthesis, preferably along a guiding element 10 attached distally tothe first stent-graft prosthesis arranged through a orifice element 610of the second stent-graft prosthesis, and through the side branch 3 tothe side vessel; connecting 850 the first stent-graft prosthesis to thesecond stent-graft prosthesis for providing a blood flow to the sidebranch vessel. A catheter 30 with a guiding element 10 can be usedbetween steps 830-840 as described above.

In a specific example the method includes delivering and assembling thesystem 100 as explained above and with a final layout illustrated inFIGS. 9 and 10 The example of such an endoprosthesis including modularembodiments and assembly is illustrated in FIGS. 9 and 10 and thecorresponding text herein. Total aortic reconstruction or repair can beprovided when implanting the entire system as shown in FIG. 10.Reference is made to FIGS. 1 and 2 and the corresponding text ininternational patent application PCT/EP2017/062809 of the same applicantas the present application, which is incorporated herein by referencefor all purposes. Partial aortic reconstruction or repair may beprovided with selected sub-modules of the system being implanted only.However, other anatomical structures may be provided for treatment withthe devices and/or systems of the disclosure, including abdominalstent-graft prostheses, peripheral stent grafts, endoluminal prosthesis,and include e.g. but not limited to peripheral veins, leg arteries,spinal vessels, neuro structures, lymphatic system, etc.

The method starts in the example with soft guidewire being inserted intoa vessel of a patient. Using a soft guidewire ensures that no part ofthe vessel is damaged during insertion. Further, the soft guidewire canbe bent and thereby be navigated through the vessel system of thepatient to a target site, here in the example the ascending aorta. Asexplained above other target sites in the body could also be chosen asan alternative.

Then, a first catheter is inserted, over the soft guidewire, into thevessel of the patient and navigated until it reaches the target site.Guided by the first catheter, a stiffer navigation element 20 is theninserted into the catheter and thus vessel of the patient.

The target site in the example is the ascending aorta where the threelegged stent-graft prosthesis 200 is then positioned via the deliverycatheter in the aortic arch. The delivered state, assembled with furthercomponents in the aortic arch is illustrated in FIG. 10.

Then a three-legged stent-graft prosthesis 200 is collapsed or folded tofit inside the first catheter 30 and pushed along it with the navigationelement/guide wire 20 may running inside the main part of thestent-graft prosthesis and extending out through one of the legs 201.

The three-legged stent-graft prosthesis 200 is provided with a guidingelement 10 attached inside one of the other legs, as described above. Inan example a location near or to the left of the aortic arch ispreferred.

Each guiding element 10 and navigation element 20 can be labelled at theend proximal end for easy identification. The proximally labelled end isconfigured to be outside of the patient during implantation.

Following, when at the correct position of the target site, thestent-graft prosthesis 200 is pushed out of the catheter 30 and allowedto fully or partially expand or unfold, as discussed above. It isrotated until the legs match the main vessel and the neck branch vesselsof the aorta. And as explained above this alignment can be performed invarious ways.

Next, when the three legged stent-graft prosthesis 200 is in place, thesystem 100 can easily be built up with further modules. As discussedabove this can be done in several ways and in this example twostent-graft prostheses 1 having side branches 3 and stent-graftprostheses 600 for extending into the branch vessel are deployedfollowing the three-legged stent-graft prosthesis 200 as described abovewith reference to FIGS. 1 and 2.

In the example illustrated in FIGS. 1 and 2 an extension stent-graftprosthesis 600 is navigated via the guiding element 10 attached insideone of the legs of the three-legged stent-graft prosthesis 200 andnavigated through the three-legged stent-graft prosthesis 200 andpositioned so that it can extend out through the leg. Here thestent-graft prosthesis 200 is expanded and connected to the leg in anoverlapping manner.

Following, the first stent-graft prosthesis 300 with the side branch 3is slid into place along the guiding element 10 and connected to thethird leg 203. After or before the deployment along the guiding element10 the second stent-graft prosthesis 300 is slid along the guidewire 20and connected to the second leg 202.

No aortic clamping stopping blood flow in the aorta or cardioplegia isnecessary. Blood flow through the aorta and the side vessels is notinterrupted during the procedure thanks to the parallel arrangement ofthe stent-graft prostheses 300.

When delivering a stent-graft prosthesis the side branch(es) 3 are atthe same time navigated into place with the stent-graft prosthesis andexpanded into, or at least towards the branch vessel. Following, anyadditional extension stent-graft prosthesis can be inserted based on thedesired need to further extend into the branch vessel.

Next, a stent-graft prosthesis 400 with two legs is moved in a collapsedstate inside the first catheter along guide wire 20 and guiding element10. The stent-graft prosthesis 400 is oriented so that the legs arepositioned towards the stent-graft prostheses 300 already connected.Each leg is guided along one of the guiding element 10 and the guidewire 20, so that each leg can be guided to one of the previousstent-graft prostheses 300 with side branches 3. When in place, thestent-graft prosthesis 1 is released from the catheter and allowed toexpand.

Alternatively, the collecting stent-graft prosthesis 400 may beconnected to the proximal end of the branched stent-graft prosthesis 300prior to connecting the side branch and/or delivering an extensionstent-graft prosthesis 600.

Next a tubular shaped stent-graft prosthesis 410, without legs or sidebranches, is pushed into place through the catheter 30, and navigatedand connected to the previous stent-graft prosthesis 400 in a similarmanner but now having both the guiding element 10 and the guide wire 20running inside. Length of the assembled prosthesis is adjustable by avariable overlap of the stent-graft prostheses chosen by the surgeonduring implantation when the interconnection of these is made.

Then a two-legged stent-graft prosthesis 420 is connected to the tubularshaped stent-graft prosthesis 1 in the same manner. This two-leggedstent-graft prosthesis 420 is oriented with the legs away from thestent-graft prostheses already distally connected upstream the aorta.These legs run along the guiding element 10 and the guide wire 20,respectively. The length of the assembled prosthesis is adjustable by avariable overlap of the stent-graft prostheses chosen by the surgeonduring implantation when the interconnection of these is made.

After connection of the two-legged stent-graft prosthesis 420, astent-graft prosthesis 310 with two side branches 3 is guided along theguiding element 10 through a delivery catheter, in a manner similar topreviously delivered stent-graft prostheses 300. When the main body ofthe stent-graft prosthesis is in approximately the right place, furthernavigation of the side branch 3 is done to be rotationally correctlyoriented towards the side vessels. The side branches 3 are thus alignedwith the branch vessels and expanded into the branch vessels. Distally,the stent-graft prosthesis 310 is connected with one of the legs of thetwo-legged stent-graft prosthesis 420.

Then, a stent-graft prosthesis 320 with two side branches 3, and furtherguiding 10 or navigation elements 20, is guided via the catheter 30,aligned with branch vessels and connected to the second leg of thetwo-legged stent-graft prosthesis 420.

Finally, a last two-legged stent-graft prosthesis 430 is positioned andthe two legs are connected to the two stent-graft prostheses 310, 320with two side branches 3, in a similar manner as described above, by useof a delivery catheter 30 and running along the guiding element 10 andthe guide wire 20, respectively.

When the system 100 is connected and complete, all remaining navigationelements 20 and catheters 30 are removed from the patient. Guidingelements 10 may be distally cut and remaining length left in place,preferably for subsequent biodegradation.

In an example, illustrated in FIG. 10, a complete system 100 is shownassembled and implanted inside an aortic arch of a patient. As can beseen, the different stent-graft prostheses 1 have been connected to eachother and side branches 3 have been extended into branch vessels andfurther extended with stent-graft prostheses 1.

Further proximal stent-graft prosthesis modules (not shown), e.g. foriliac artery reconstruction or repair, may be provided and implanted,such as connected to the proximal end of the stent-graft prosthesis 430.

Further examples of methods and procedures are given below:

A method is provided for navigating a stent-graft prosthesis to a branchvessel. The method includes providing a stent-graft prosthesis 200, 300,310, 320 and navigating the lateral side branch into or towards a branchvessel by moving the lateral side branch using a guiding element 10. Themethod may include expanding a stent-graft prosthesis delivered throughthe lateral side branch 3 from a collapsed state into the branch vesselwhen navigated in position at the branch vessel. The method may includeinterconnecting an expansion element 600 at the lateral side branch andinto the branch vessel for further extension into the branch vessel,wherein the expansion element preferably is a stent-graft prosthesis.

A method is provided for interconnecting a plurality of stent-graftprostheses. The method includes providing a stent-graft prosthesishaving a bendable guiding element connected at an exit of a side branch.The method may include interconnecting a plurality of such stent-graftprostheses including sliding a catheter by means of a guiding mate 9along the guiding element to the exit of the side branch and deliveringanother stent-graft prosthesis through the catheter along the bendableguiding element for interconnection of stent-graft prostheses. Thestent-graft prostheses preferably have a same dimension at theinterconnection.

A medical procedure is provided including accessing 710 a target sitebeing a vessel in a patient; delivering 720 a first stent-graftprosthesis to the inside of the vessel at the target site through adelivery catheter, wherein the target site has a side branch vessel;delivering 730 a second stent-graft prosthesis to the first stent-graftprosthesis; connecting 740 the first stent-graft prosthesis to thesecond stent-graft prosthesis for providing a blood flow to the sidebranch vessel, wherein the delivery of the second stent-graft prosthesisincludes sliding a catheter along a guiding element 10 to a positioninside a lumen of a side branch of the first stent-graft prosthesis; andexpanding the second stent-graft prosthesis for connecting to the firststent-graft prosthesis.

A medical procedure is provided including accessing 810 a target sitebeing a vessel in a patient; delivering 820 a first stent-graftprosthesis to the inside of the vessel at the target site through adelivery catheter, wherein the target site has a side branch vessel;expanding 830 the side branch 3; delivering 840 a second stent-graftprosthesis to the first stent-graft prosthesis and through the sidebranch 3 to the side vessel; and connecting 850 the first stent-graftprosthesis to the second stent-graft prosthesis for providing a bloodflow to the side branch vessel.

Another example of a delivery procedure is as follows:

-   -   1. Inserting a delivery system via an introducer sheath into a        patient's body.    -   2. Opening an outer sheath 9 and removing from a proximal end of        a prosthesis towards a side branch prosthesis direction. Keep        opening till the side branch prosthesis is released and expanded        fully.    -   3. Stopping opening till the side branch prosthesis is fully        exposed.    -   4. Adjusting the position of the prosthesis for initial        matching.    -   5. Inserting a double lumen catheter 30 over a pre-loaded        guiding element 10 and allow it travel to the side branch        prosthesis, till it hits the end at connection point 11.    -   6. Insert an additional guidewire via the double lumen catheter        30 and make it protrude from the side branch 3.    -   7. Optionally performing further adjustment of the position of        the prosthesis.    -   8. Once the position of the side vessel is identified and        confirmed, advance the additional guidewire forward to secure        the position.    -   9. Once the additional guidewire is securely staying in the side        vessel, remove the double lumen catheter and deliver the        connecting prosthesis 600 by using the additional guidewire and        guiding element 10 over orifice element 610 for desired overlap.    -   10. Once the connecting prosthesis 600 is in side vessel and        fully expanded, remove the rest of the outer sheath 9 of the        previous prosthesis releasing it entirely.    -   11. Unlock the guiding element 10 from the side branch        prosthesis and remove all guidewires and delivery system from        the patient's body.

The present disclosure has been described above with reference tospecific examples. However, other examples than the above described areequally possible within the scope of the disclosure. Different methodsteps than those described above, may be provided within the scope ofthe disclosure. The different features and steps of the disclosure maybe combined in other combinations than those described. The scope of thedisclosure is only limited by the appended patent claims.

1. A medical system including a first main stent prosthesis having atleast one lateral branch, a second side stent-graft prosthesis having abody of a generally tubular wall structure, and a guiding element;wherein: said lateral branch having a distal orifice at a distal endbeing configured for receiving said second side stent-graft prosthesisconnectable thereto, characterized in that said tubular wall structureof said second side-stent graft prosthesis including an orifice elementconfigured for receiving said guiding element through its orifice, andsaid guiding element having a distal end positioned proximally at aninterior and at a distance from said distal orifice of said lateralbranch at a connection point of said side branch; such that saidstent-graft prosthesis is arrangeable slideably along said guidingelement over said orifice element to said orifice of said lateral branchfor delivery and deployment of said side stent-graft prosthesis,preferably through a delivery lumen of a catheter with its lumenthreadable over said guiding element, wherein said second sidestent-graft prosthesis extends distally beyond said connection pointwhen moved with its orifice element over said guiding element forengagement at said connection point; and said orifice element preferablybeing a guiding mate.
 2. The system according to claim 1, wherein saidwall structure of said second side stent-graft prosthesis having anoverlap region for interconnection to said distal end of said first mainstent-graft prosthesis, wherein said orifice element is arranged at saidoverlap region, wherein said overlap region is preferably arranged at aproximal end region of said body; and wherein said guiding elementpreferably is a textile thread or suture thread, optionally with aradiopaque marker, such as a fiducial marker and/or a radiopaqueelongate marker extending at least along a portion of a length of saidguiding element.
 3. The system according to claim 2, wherein saidorifice element of said second side stent-graft prosthesis being anaperture in said tubular wall structure, wherein said aperture ispreferably an eyelet in a wall material of said wall and preferably hasa reinforced periphery edge or a reinforced peripheral region such as insaid wall material adjacent said eyelet.
 4. The system according toclaim 2, wherein said tubular wall structure of said second sidestent-graft prosthesis having an outside and said orifice element isarranged at said outside of said wall.
 5. The system according to claim4, wherein said orifice element of said second side stent-graftprosthesis is a side opening such as an eyelet or a tubular element forreceiving said guiding element.
 6. The system according to claim 3,wherein said tubular wall of said second side stent-graft prosthesis hasan inside and said orifice element includes a tubular structure arrangedat said inside proximally and towards said aperture for receiving saidguiding element.
 7. The system according to claim 1, wherein saidorifice element of said second side stent-graft prosthesis is arrangedat a rotational position of said tubular wall structure for facilitatinga rotational position of said body upon delivery.
 8. The systemaccording to claim 1, wherein said orifice element of said second sidestent-graft prosthesis being a guiding mate configured for receivingsaid guiding element such that said stent-graft prosthesis is configuredto slide along said guiding element over said guiding mate to saidorifice of said lateral branch.
 9. The system according to claim 1,wherein the guiding element is made of a biodegradable material.
 10. Akit of a system according to claim 1, including said first main stentprosthesis having a lateral branch and a second side stent-graftprosthesis, and at least one of said guiding element, said guidingelement being bendable and/or flexible and being distally permanently orreleasably attached to said lateral branch at a distance from saiddistal orifice of said branch.
 11. A system including said kit of claim10, wherein said guiding element is proximally extending through saidorifice element for guiding said stent-graft prosthesis to said lateralbranch towards said distal orifice of said branch during delivery, suchthat said orifice element of said stent-graft prosthesis upon deliveryis arranged with a proximal overlap in said lateral branch.
 12. A methodof manufacture a medical system of stent-graft prostheses, comprisingproviding a first main stent prosthesis having at least one lateralbranch, a second side stent-graft prosthesis having a body of agenerally tubular wall structure, and a guiding element; said lateralbranch having a distal orifice at a distal end for receiving said secondside stent-graft prosthesis connectable thereto, providing said tubularwall structure of said second side-stent graft prosthesis with anorifice element configured for receiving said guiding element throughits orifice, and positioning said guiding element with a distal endproximally at an interior and at a distance from said distal orifice ofsaid lateral branch at a connection point of said side branch; arrangingsaid stent-graft prosthesis is slideably along said guiding element oversaid orifice element to said orifice of said lateral branch for deliveryand deployment of said side stent-graft prosthesis, preferably through adelivery lumen of a catheter with its lumen threadable over said guidingelement, such that said second side stent-graft prosthesis upon deliveryextends distally beyond said connection point when moved with itsorifice element over said guiding element for engagement at saidconnection point.
 13. (canceled)